NCT02501733已完成不适用
Medacta GMK Sphere® Medial Pivot, Cruciate Substituting Multicenter, Post-Market Outcomes Study
Medacta USA10 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 10
- 主要终点
- Evaluate the change in Forgotten Knee Scores (FJS) of those patients receiving the Medacta GMK Sphere from baseline to years 2 and 5 post-operatively.
研究概览
简要总结
This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere® knee at the two and five year time points. 70 subjects, enrolled at the data coordinating center in Medacta GMK Sphere® vs Posterior Stabilized study (WIRB Pro Num: 20141994) and randomized to the Sphere arm, will have their data utilized for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients willing to sign the informed consent
- •Patients able to comply with follow-up requirements including postoperative weight bearing restrictions and self evaluations.
- •Male and non-pregnant female patients ages 21 - 80 years of age at the time of surgery.
- •Patients requiring a primary total knee replacement.
- •Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- •Patients with intact collateral ligaments.
排除标准
- •Patients with inflammatory arthritis.
- •Patients that are morbidly obese, body mass index (BMI) >
- •Patients with a history of total or unicompartmental reconstruction of the affected joint.
- •Patients that have had a high tibial osteotomy or femoral osteotomy.
- •Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- •Patients that are immunologically compromised, or receiving chronic steroids (> 30 days).
- •Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- •Patients with knee fusion to the affected joint.
- •Patients with an active or suspected latent infection in or about the knee joint.
- •Patients that are prisoners.
结局指标
主要结局
Evaluate the change in Forgotten Knee Scores (FJS) of those patients receiving the Medacta GMK Sphere from baseline to years 2 and 5 post-operatively.
时间窗: Baseline, 2 and 5 year time points
Knee function-patients ability to forget the artificial joint in everyday life.
次要结局
- Total Knee Society Score (KSS)(Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years.)
- Krackow Activity Scale (KAS)(Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years)
- Radiographic Analysis(Pre-operative, 6 weeks, 3-6 months, 1,2,3,4 and 5 years)
- AP long standing X-ray(Pre-operative and 6 weeks)
研究者
研究点 (10)
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